Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00481520
Status:
COMPLETED
Last Update Posted:
2009-09-30
First Post:
2007-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581984', 'term': 'SAM-531'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'dispFirstSubmitDate': '2009-09-28', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-28', 'studyFirstSubmitDate': '2007-05-30', 'dispFirstSubmitQcDate': '2009-09-28', 'studyFirstSubmitQcDate': '2007-05-30', 'dispFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Routine safety and tolerability will be evaluated.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'This study will also investigate the pharmacokinetics(PK, how the drug is metabolized) and pharmacodynamics (PD, how the drug affects bodily and mental function) of SAM-531 compared to placebo.', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The primary purpose of the study is to assess whether SAM-531, an investigational drug, is safe and well tolerated, compared with placebo (a medically inactive substance), in subjects with mild to moderate Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Signed and dated written informed consent obtained from the subject or the subject's legally authorized representative (LAR) or next of kin (if applicable), in accordance with the local regulations. The subject's caregiver must also consent to participate in the study.\n2. Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.\n3. Men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive. Postmenopausal women must have had 12 months of spontaneous amenorrhea. Surgically sterile women are defined as having a hysterectomy, bilateral ovariectomy \\[oophorectomy\\], or bilateral tubal ligation. Men who are sexually active will need to agree to use a form of contraception that is satisfactory as per the investigator.\n4. Able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.\n\nExclusion Criteria\n\n1. Significant neurological disease other than Alzheimer's disease, which may affect cognition (eg, epilepsy, Parkinson disease).\n2. Current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Version (DSM-IV-TR).\n3. Current clinically significant systemic illness, which is likely to deteriorate or affect the subject's safety, influence cognitive assessment or ability to complete the study.\n4. Any clinically important deviation from normal limits in physical and neurological examination, vital signs, on electrocardiogram (ECG) or clinical laboratory test results that could compromise the study or be detrimental to the subject."}, 'identificationModule': {'nctId': 'NCT00481520', 'briefTitle': "Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': "A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) Trial of Multiple Ascending Fixed Doses of SAM-531 in Subjects With Mild to Moderate Alzheimer's Disease.", 'orgStudyIdInfo': {'id': '3193A1-2000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: SAM-531']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'SAM-531', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '07740', 'city': 'Long Branch', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.30428, 'lon': -73.99236}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '05201', 'city': 'Bennington', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}